§ Mr. Ashleyasked the Secretary of State for Social Services if he will detail the requirement on drug companies to inform the Committee on Safety of Medicines of reported adverse reactions to the drugs they produce; on how many occasions companies have failed to meet this requirement; what sanctions may be imposed; and how often they have been used.
§ Mr. Kenneth ClarkePharmaceutical companies are required to maintain a register of reports of adverse reactions occurring in the United Kingdom or other countries in respect of any of their products licensed in the United Kingdom. Copies of such reports must be forwarded to the licensing authority for the information of the Committee on Safety of Medicines within a period of one month for all reactions occurring within the United Kingdom in respect of newly marketed products and for serious reactions in respect of other products. We have never established any significant breach of these legal requirements. If it were to be established that such a breach had occured, the licensing authority could, after referring 437W the matter to the Committee on Safety of Medicines, suspend or revoke the product license. Such action has not so far been necessary.
Following the comments of the Grahame-Smith working party of the CSM on adverse reactions, we are now discussing with the industry the need for clarification of the instructions and advice to companies on what and how to report to ensure that the legal requirements are absolutely plain and that the data are submitted in the most useful form.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) whether the drug company Ciba-Geigy has given the Committee on Safety of Medicines any suspected adverse reaction reports to the drugs Butazolidin and Tanderil; what types of reactions have been identified; and what proportion of them occurred in the United Kingdom;
(2) how many suspected adverse reactions to the drugs Butazolidin and Tanderil have been reported via the yellow card system to the Committee on Safety of Medicines since 1964; in how many cases the reaction was a death; what response the committee made to the adverse reaction reports; and whether any warnings have been circulated to doctors.
§ Mr. Kenneth ClarkeButazolidin and Tanderil are brand names for two of a number of products containing the substances phenylbutazone and oxyphenbutazone respectively. The Committee on Safety of Medicines has received 1,685 reports of suspected adverse reactions associated with all products containing phenylbutazone, including 442 where the patient died; and 503 reports associated with oxyphenbutazone including 131 where the patient died. The majority of reports received from Ciba-Geigy of adverse reactions associated with its products concern reactions occurring within the United Kingdom, and the types of reactions they have reported are the same as those spontaneously reported to the committee by doctors in this country, including blood disorders and gastro-intestinal intolerance and bleeding.
The former Committee on Safety of Drugs issued a warning in 1965 to doctors about safety hazards associated with phenylbutazone and oxyphenbutazone, and a review of this class of drugs was carried out in the late 1970s by the Committee on Review of Medicines. As a result, the advice to doctors contained in product data sheets relating to products containing phenylbutazone and oxyphenbutazone was amended, to include warnings referring to gastro-intestinal intolerance and bleeding, and blood disorders.
I am aware of public concern about this matter and I can assure the right hon. Member that the CSM has all products in this class under close review.